Actívatexto: Feasibility and Acceptability of a Mobile Intervention That Promotes Smoking Cessation and Physical Activity among Latinos

Abstract The purpose of this study was to assess the feasibility and acceptability of a mobile intervention that promotes smoking cessation and physical activity among Latinos living in the United States. Twenty Latino adults who smoked and did not meet recommended levels of physical activity were recruited using community-based recruitment strategies. Participants received Actívatexto, a theory-based, culturally accommodated, 12-week text messaging intervention (available in English and Spanish) that promotes smoking cessation and physical activity. Actívatexto integrates four components: (i) a text messaging program, (ii) a wearable device, (iii) an online dashboard where the research team manages participants’ incoming and outgoing data from both the text messaging program and wearable device, and (iv) nicotine replacement therapies (NRT). We assessed self-reported 7-day point prevalence smoking abstinence at month 3, weekly minutes of moderate to vigorous physical activity (MVPA), pharmacotherapy adherence, and satisfaction. At baseline, participants’ mean age was 47.3 years old (SD 16.0), 55% of participants were female, and 60% indicated that Spanish was their language of preference. Seventy-five percent of participants smoked 1–10 cigarettes daily and 35% smoked their first cigarette within 5 minutes after waking up. At month 3, 14 participants (70%) self-reported 7-day point prevalence smoking abstinence (90% follow-up rate). Fitbit-assessed mean minutes of MVPA per week increased from 113 (SD 127; range: 0–399) at week 1 to 177 (SD 163; range: 0–513) at month 3 (P = 0.15). Sixteen participants (88.9%, 16/18) reported NRT use in the past 90 days. Most participants reported being extremely satisfied or satisfied with the intervention (88.9%, 16/18). Significance: Actívatexto resulted in a noteworthy cessation rate at month 3 (70%), increased mean weekly minutes of MVPA, produced high use of NRT, and was well received by participants. Additional testing in a randomized clinical trial is warranted to assess the efficacy of the intervention.


Introduction
Latinos are the largest minority group in the United States, accounting for 17.4% of the U.S. population, and are projected to grow to nearly 30% by 2060 (1, notable cessation rate (30%) among Latino adults (16).To the best of our knowledge, no study has leveraged the role of physical activity in enhancing cessation rates among Latino adults.Moderate to vigorous physical activity (MVPA) is associated with outcomes that predict smoking cessation, including management of relapse/lapse, acute relief from nicotine withdrawal, and greater self-efficacy to quit smoking (19)(20)(21)(22).MVPA also lessens fear about weight gain, a frequent concern among individuals who smoke (23).In 2019, Ussher and colleagues conducted a Cochrane review on exercise and physical activity interventions for smoking cessation, concluding that there is insufficient evidence on the efficacy of incorporating exercise and physical activity into smoking cessation treatment (24).Estimates of treatment effect were of low or very low certainty because of concerns about risk of bias and imprecision (24).Nevertheless, four studies have shown higher cessation rates among individuals who smoke assigned to an intervention that promotes MVPA compared with control (25)(26)(27)(28).However, these trials were hampered by limitations including small sample sizes, absence of men, exclusion of non-English speaking individuals, or no representation of racial and ethnic minorities (25)(26)(27)(28).Moreover, these studies have relied on highly structured, supervised, vigorous exercise at research-based fitness facilities, which may not be broadly disseminated.Furthermore, some of these studies used self-reported data on physical activity.The purpose of this pilot study was to assess the feasibility and acceptability of Actívatexto, a mobile intervention that promotes smoking cessation and physical activity among Latino adults living in the United States.

Study Design
This was a single-arm pilot study with 20 Latino adults who smoke and do not meet recommended levels of physical activity.Participants received Actívatexto, a culturally accommodated mobile intervention that promotes smoking cessation and physical activity.Study procedures were approved and monitored by the University of Rochester Medical Center (URMC) Institutional Review Board (protocol number STUDY00007515).The study was conducted in accordance with the Declaration of Helsinki.Participants were compensated with a $30 gift card for enrolling in the study and a $50 gift card for completing the 12-week follow-up assessment.

Recruitment
Recruitment was conducted in New York State by a team of bilingual (English and Spanish) trained research staff between January and May 2023.Recruitment strategies included study presentations in community-based organizations, malls, Latino festivals, referrals from the Wilmot Tobacco Cessation Center at the URMC, and word of mouth from community partners.

Eligibility
Individuals were eligible if they (i) self-identified as Latino(a) and/or Hispanic; (ii) knew how to speak and read English and/or Spanish; (iii) were 21 years of age or older; (iv) did not meet the recommended 150 minutes of MVPA per week (measured by the International Physical Activity Questionnaire; refs.29,30); (v) smoked at least 3 days per week; (vi) were interested in quitting smoking in the next 30 days; (vii) had a cellphone with text messaging capability; (viii) knew how to utilize text messages; (ix) were willing to wear a wearable device to monitor physical activity; and (x) were willing to complete all study visits.Individuals were not eligible if they (i) used tobacco products other than cigarettes in the past 30 days (including e-cigarettes); (ii) were pregnant or breastfeed-ing; (iii) were planning to move from their current residence in the upcoming 6 months; (iv) had another household member enrolled in the study; and (v) were unable to become more physically active or engage in a fitness appraisal [as determined by the Physical Activity Readiness Questionnaire, PAR-Q (31,32)].The PAR-Q is a simple questionnaire designed to determine whether or not it is safe for an individual to engage in physical activity (31,32).

Screening and Consent
Trained research staff conducted the eligibility assessment over the phone.Individuals who were eligible to participate in the study were scheduled for a baseline appointment in-person or by telephone.During the baseline appointment, staff discussed all aspects of study participation, answered any questions, and guided individuals through the process of written informed consent.Eligibility assessment and consent were available in the participant's language of preference, either English or Spanish.

Intervention
Actívatexto is a theory-based, culturally accommodated, 12-week text messaging intervention (available in English and Spanish) that promotes both smoking cessation and physical activity.Actívatexto integrates four components: (i) a text messaging program that promotes both smoking cessation and physical activity, (ii) wearable devices to monitor physical activity, (iii) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices, and (iv) smoking cessation pharmacotherapy (i.e., NRTs).Actívatexto builds upon Decídetexto, a mobile intervention that solely promotes smoking cessation among Latinos (17,18).Actívatexto was informed by (i) social cognitive theory, (ii) literature reviews, (iii) feedback from key stakeholders, tobacco treatment specialists, and exercise physiologists, and (iv) interviews with Latino adults who smoke (33).The intervention was refined by a multidisciplinary Community Advisory Board (CAB), where each member represented different Latin American countries to ensure the cultural and linguistic congruency of each intervention component.

Text Messages
Similar to Decídetexto (17,18), the text messaging component of Actívatexto allows three levels of interactivity: (i) prescheduled standard messages, (ii) keyword-triggered standard messages, and (iii) counselor-personalized responses.

Prescheduled Standard Messages:
The text messaging library consisted of messages covering 10 themes: education, intratreatment social support, extra treatment social support, coping with triggers, stimulus control, vicarious experience, social norms, relapse prevention, reward, and logistics.The text messages were delivered according to an algorithm based on four sequential phases of the quitting process: (i) Pre-quit (30 days), (ii) Quit-Day, (iii) Postquit Intensive (28 days), and (iv) Post-quit Maintenance (6 weeks).Actívatexto also included a Relapse track (8 days).

Personalized Responses:
The intervention encouraged participants to text any concerns and/or questions to the program (e.g., on day 1 of the text messaging intervention, participants received the following message: "Hi, I am your counselor.Feel free to text me anytime-I am here to help you Monday through Friday from 8 AM to 6 PM.When you text me, I will reply as soon as possible").Research staff, who are also trained tobacco treatment specialists, answered these messages following standard protocols (e.g., answering questions on pharmacotherapy use and side effects).Staff monitored and triaged queries daily, responding within 48 hours of receipt of text messages.

Wearable Devices
Participants were provided with a Fitbit Versa 4 device.Fitbit devices provide acceptably accurate measures of MVPA (34)(35)(36)(37).Providing participants with a Fitbit device homogenized the tracking of physical activity compared with providing other wearable devices (e.g., Apple Watch) or using smartphone applications (e.g., Health by iOS), which would not have been standardized across all operating systems (e.g., Google's Android and Apple's iOS).Research staff mailed the Fitbit devices to each participant and helped them set up their accounts.Participants were instructed to wear the Fitbit on their wrist daily and received weekly messages regarding their weekly levels of physical activity.The goal was for participants to complete at least 150 minutes of MVPA each week: 150 minutes of moderate activity or 75 minutes of vigorous activity, or a combination of both.Finally, Fitbit devices provide some motivational components for physical activity including reminders about long inactive periods and a celebration on the device when individuals step goal for the day has been reached.

Online Dashboard
Actívatexto relied on an online dashboard where the research staff managed participants' incoming and outgoing data from both the text messaging program and wearable devices.Actívatexto synchronized the Fitbit Versa 4 devices with the text messaging platform.This synchronization allowed research staff to monitor participants' physical activity on a weekly basis.Data were used to send automated individualized text messages to participants indicating their progression toward completing the 150 minutes of MVPA per week.

NRT
The use of NRT in this study followed the Clinical Practice Guideline for Tobacco Use and Dependence (38).Nicotine patches, gum, and lozenges were offered to participants at no cost.Participants who smoked more than 10 cigarettes per day (CPD) were offered ten weeks of nicotine patches (21 mg nicotine patches to be used during the first 6 weeks, followed by 14 mg nicotine patches for 2 weeks, and 7 mg patches for the last 2 weeks).Participants who smoked between six and 10 CPD were offered 8 weeks of nicotine patches (14 mg nicotine patches to be used during the first 6 weeks, followed by 7 mg patches for the last 2 weeks), gum (2 mg nicotine gum), or lozenges (2 mg nicotine lozenges).Participants who smoked five or less CPD were offered 6 weeks of nicotine patches (7 mg nicotine patches), gum (2 mg nicotine gum), or lozenges (2 mg nicotine lozenges).The gum was available in the following flavors: fruit chill, cinnamon, and mint.Participants who were interested in using NRT received them via postal mail.This approach has been used in previous studies (16)(17)(18).

Assessments
Assessments were completed in the language of preference of the participant, either English or Spanish.The baseline survey collected sociodemographic variables such as age, gender, sexual orientation, education level, language of preference, and country of birth.Smoking-related variables collected at baseline included the number of CPD, time to first cigarette, use of menthol cigarettes, if they made a quit attempt in the previous year, smoking in the social network, and their self-efficacy for abstinence [measured by the smoking self-efficacy questionnaire (SEQ-12)] (39, 40).The SEQ-12 consists of 12 items, and each item is rated on a 5-point Likert scale (1 = "Not at all sure" to 5 = "Absolutely sure"; refs.39,40).SEQ-12 scores range from 12 to 60 with higher scores indicating greater self-efficacy (39,40).Finally, participants were asked about their self-efficacy for physical activity [measured by the self-efficacy for physical activity (SEPA) scale] (41,42).The SEPA scale consists of 5 items, and each item is rated on a 5-point Likert scale (1 = "Not confident" to 5 = "Extremely confident"; refs.41,42).SEPA scores range from 5 to 25 with higher scores indicating greater self-efficacy (41,42).
The Fitbit Versa 4 devices provide data on "active minutes."Active minutes, calculated within the proprietary algorithms of Fitbit, are defined as the time spent doing MVPA.For moderate-intensity physical activity, the heart rate should be between 64% and 76% of the maximum heart rate (43).For vigorousintensity physical activity, the heart rate should be between 77% and 93% of the maximum heart rate (43).The maximum heart rate is a custom rate based on age and is the subtraction of age in years from 220 (43).Each minute of moderate-intensity physical activity equals one active minute.Each minute of vigorous-intensity physical activity equals two active minutes.These measures are based on guidelines for physical activity (44-46).Adherence to Fitbit Versa 4 wear was defined as the total percentage of device wear during the intervention period (47).Consistent with previous criteria, Fitbit wear (i.e., whether or not a participant was considered to have worn the device for a particular day) was determined by an objective record of 100 steps in a day (48)(49)(50).
Three months after enrollment, a follow-up assessment was conducted.The primary outcome was self-reported 7-day point prevalence abstinence (not smoking any cigarettes in the past 7 days).Secondary outcomes were pharmacotherapy adherence, self-efficacy, and satisfaction.Pharmacotherapy use was assessed by the question "Have you used the nicotine patches/gum/lozenges in the last 3 months?"(Yes/No).If a participant indicated NRT use in the last 3 months, the following question was asked "In the last 3 months, how many days did you use the nicotine patches/gum/lozenges?" Self-efficacy for smoking cessation and physical activity were measured with the SEQ-12 and SEPA scale, respectively (39)(40)(41)(42).Acceptability measures included questions such as "How satisfied are you with the smoking cessation text messaging program?" (1 = "Extremely unsatisfied" to 5 = "Extremely satisfied"), "Would you recommend this program to a friend?"(Yes/No), "In general, how much did this program help you quit smoking cigarettes?" (1 = "Not at all" to 4 = "A lot"), and "In general, how much did this program help you be physically active?"(1 = "Not at all" to 4 = "A lot").

Analysis
Frequencies were calculated for categorical variables.Means and SDs were calculated for continuous variables.Primary analysis on smoking cessation was conducted using the Russell standard, treating those lost to follow-up as participants who continued smoking (51).The secondary analyses on MVPA, pharmacotherapy use, self-efficacy, and satisfaction were conducted using complete case analysis, in which missing values in the outcome were considered to be missing.Weekly minutes of MVPA, self-efficacy for smoking cessation, and SEPA at baseline and follow-up were compared using paired sample t tests to examine differences.

Data Availability Statement
The data generated in this study are available upon request from the corresponding author.

Results
Fifty-eight Latino adults who smoked were identified.Among these, 46 were assessed for eligibility; 25 were eligible to participate in the study.Twenty Latino adults who smoked and did not meet the recommended levels of MVPA consented to participate in the study and completed the baseline assessment (Fig. 1).
At baseline, mean age among participants was 47.3 years old (SD 16.0), 55% of participants were female, 75% were heterosexual or straight, 80% had completed high school or lower educational level, and 60% indicated that Spanish was their language of preference.Eight participants (40%) were born in Cuba, 6 (30%) in the United States, 3 (15%) in Puerto Rico, and one each from three other countries.Most participants (75%) smoked 1-10 cigarettes daily, 35% smoked their first cigarette within 5 minutes after waking up, 60% used menthol cigarettes and, on average, 3 of their 5 closest friends smoke (mean 3.3, SD 1.7).Most participants (75%) tried to quit smoking in the past year and 60% have used pharmacotherapy and electronic cigarettes for smoking cessation in their lifetime.The mean scores of self-efficacy for smoking cessation and physical activity were 30.2 (SD 10.6) and 12.3 (SD 3.9), respectively (Table 1).Seventeen participants (85%) requested NRT at baseline: 9 (45%) requested patches, 7 (35%) requested gum, and 1 (5%) requested lozenges.
At month 3, 14 participants (70%) self-reported 7-day point prevalence abstinence.The follow-up rate was 90% (18/20).Sixteen participants self-reported using NRT for at least one day.Using an analysis with participants who selfreported using NRT for at least one day, on average, participants self-reported using NRT for 39.6 days (SD 31.7,range: 3-90).Mean scores of self-efficacy for smoking cessation increased significantly from 30.2 (SD 10.6) at baseline to 47.8 (SD 13.0) at follow-up (P < 0.01).Mean scores of SEPA increased from 12.3 (SD 3.9) at baseline to 14.6 (SD 4.4) at follow-up, although the difference was not statistically significant (P = 0.2).Most participants reported being extremely satisfied or satisfied with the intervention (88.9%, 16/18), and said they would recommend the program to a friend (94.4%, 17/18).Moreover, most participants reported that the program helped them a lot to quit smoking (88.9%, 16/18) and be physically active (83.3%, 15/18).

Discussion
To the best of our knowledge, Actívatexto is the first mobile intervention that promotes smoking cessation and physical activity among Latinos.This work Quit attempt in past year 15 (75.0%)Use of cessation pharmacotherapy in the past a 12 (60.0%)Use of E-cigarettes for cessation in the past 12 (60.0%) Self-efficacy for abstinence b , mean (SD) 30.2 (10.6)Self-efficacy for physical activity c , mean (SD) 12.3 (3.9) Abbreviations: CPD: cigarettes per day; SD: standard deviation.a Cessation pharmacotherapy included the nicotine patch, nicotine gum, nicotine lozenge, nicotine nasal spray, nicotine inhaler, Chantix/Varenicline, and Zyban/Bupropion.b Self-efficacy for abstinence was measured by the smoking self-efficacy questionnaire (SEQ-12).SEQ-12 scores range from 12 to 60 with higher scores indicating greater self-efficacy.c Self-efficacy for physical activity was measured by the SEPA scale.SEPA scores range from 5 to 25 with higher scores indicating greater self-efficacy.
demonstrates that it is feasible to recruit Latino adults who smoke and do not meet the recommended levels of physical activity.The 70% smoking cessation rate seen at month 3 is extremely promising.A previous feasibility study of a mobile intervention that solely promote smoking cessation among Latinos interested in quitting smoking in the next 30 days found a cessation rate of 30% at month 3 (15).A two-arm randomized clinical trial comparing Actívatexto to a mobile intervention that solely promotes smoking cessation is warranted to assess the marginal effect of adding physical activity into smoking cessation treatment among Latinos.
The Actívatexto intervention increased Fitbit-assessed mean minutes of MVPA per week, although the difference was not statistically significant.Despite nonsignificant statistical results, an average increase of 64 minutes of MVPA per week provides important health benefits (52,53).This suggests that a mobile intervention that promotes smoking cessation and physical activity may have a On average, participants adhered to wearing their Fitbit Versa 4 device 69.2% of the days during the 3-month period.This result is appropriate as it falls within the range of previously reported adherence to Fitbit wear.Halliday and colleagues, reported that among parents of children with cancer (n = 20) enrolled in a walking intervention, adherence to Fitbit wear at week 12 was 55.2% (49).Moreover, Schumacher and colleagues, reported that among women (n = 20) enrolled in a partner-based physical activity program, adherence to Fitbit wear at week 6 was 97% (48).
In this study, participants showed high interest in using NRT, with 88.9% (16/18) of participants using NRT for at least one day and, among those who used NRT for at least one day, used them for 39.6 days.This high level of interest is consistent with new smoking cessation studies among Latinos (16).Moreover, this level of interest challenges older studies that have suggested limited interest in pharmacotherapy use among Latinos (8,9).
This study provides preliminary evidence that Actívatexto has the potential to increase both self-efficacy for smoking cessation and physical activity.This result is relevant given that self-efficacy is one of the most consistent predictors of smoking cessation and physical activity in the literature (55,56) and an important component of the social cognitive theory (57).Finally, Actívatexto was well received by participants, most of whom reported high levels of satisfaction.
Engaging in physical activity can put individuals at risk of injury (58,59).This study used the PAR-Q to identify individuals who were at risk of injury, making them ineligible to participate in the study.Eight of the 21 individuals who were ineligible to participate in the study (38.1%) were due to the use of the PAR-Q.A pragmatic approach would have been appropriate for individuals who were at risk of injury to receive authorization from their primary care physician to engage in physical activity.Future studies could adopt this pragmatic approach to maximize study participation and make the study results more generalizable.

Limitations and Strengths
This study has some limitations that should be considered when interpreting the findings.First, the study had a small sample size.However, the enrollment of 20 participants was sufficient to assess the feasibility and acceptability of Actívatexto.Second, no comparison group was available, limiting our ability to assess the efficacy of the intervention.Third, biomarkers (e.g., cotinine, carbon monoxide) were not used to verify smoking abstinence, making it possible that the actual cessation rate was lower.However, self-reported smoking abstinence has been judged to be appropriate for minimal contact community interventions that do not involve face-to-face contact (60).Fourth, the study solely focused on MVPA.Future studies should consider promoting and monitoring light intensity physical activity as evidence shows that it provides health benefits (61)(62)(63).Fifth, findings should be generalized cautiously.For example, participants were interested in quitting smoking in the next 30 days and study participation was limited to one member per household.Finally, most participants in this study were born in Cuba, the United States, and Puerto Rico, reflecting the Latino groups with the highest smoking rates (4).It remains unknown whether these preliminary results can be generalized to the entire Latino population.
Despite these limitations, this study has several strengths.First, this study builds upon an established history of tobacco cessation research with the Latino community (13)(14)(15)(16)(17)(18).Second, this work is grounded in principles of communitybased participatory research (64).Community-based participatory research is a partnership approach that involves community members across all phases of research (64).This approach ensures that the research is appropriate, relevant, and meaningful to the Latino community.Third, the study has an appropriate representation of men (45% of the total sample size).This is relevant given the historic underrepresentation of men in studies promoting both smoking cessation and physical activity (24)(25)(26)(27)(28). Fourth, the intervention promoted physical activity without relying on highly structured, supervised exercise at research-based fitness facilities, making it more accessible.Finally, the inclusion of Spanish-speaking participants is another study strength.Twelve participants (60%) completed the study in Spanish.

Conclusion
Actívatexto, a mobile intervention that promotes smoking cessation and physical activity among Latinos, resulted in a noteworthy cessation rate at month 3 (70%), increased mean minutes of MVPA per week, produced high use of NRT, increased self-efficacy for smoking cessation and physical activity, and was well received by participants.Additional testing in a formal randomized clinical trial is warranted to assess the efficacy of the intervention.
Standard Messages: These messages consisted of automated immediate responses sent to participants who texted one of the following keywords: (i) Family, (ii) Stress, (iii) Crave, (iv) Patch, and (v) Gum.In addition, throughout the 12-week program, participants received six response-triggered (YES or NO) messages to assess their smoking status (e.g., Have you smoked a cigarette (even a puff) in the last 7 days?Text YES or NO).If participants indicated that they were smoking, the intervention guided them to selecting a new Lara et al. quit date.Participants could stop receiving the text messages at any moment by texting the keyword "Stop".

FIGURE 1
FIGURE 1 Study design flow diagram.
positive impact on MVPA and health among Latinos.This study adds valued insights to the expanding literature on promoting physical activity via mobile interventions.Aguiñaga and colleagues, conducted a single-arm pilot study with 20 middle-aged and older Latinos participating in BAILA TECH, a Latin dance program that encompassed Fitbit devices and text messages.The BAILA TECH intervention significantly increased Fitbit-assessed MVPA (d = 0.69; ref. 54).

TABLE 1
Baseline characteristics of participants